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510(k) K913490

PHOENIX BURR HOLE BUTTON, BURR 1 by Phoenix Bioengineering, Inc. — Product Code GXR

K913490 is an FDA 510(k) premarket notification submitted by Phoenix Bioengineering, Inc. for the device "PHOENIX BURR HOLE BUTTON, BURR 1". The FDA issued a decision of Substantially Equivalent on January 13, 1992. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Phoenix Bioengineering, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1992
Date Received
August 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by Phoenix Bioengineering, Inc.

  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K904434 — SEXTON CYSTOTOMY URINE PUMP (SCUP2) (February 1, 1991)

Other clearances for product code GXR

  • K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (March 16, 2026)
  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221606 — Absorbable Cranial Flap Fixation System (November 21, 2023)
  • K192310 — Flap Fixator, Burr Hole Cover (June 3, 2020)
  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K160739 — Cranial COVER (June 12, 2016)
  • K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (June 9, 2016)
  • K140309 — CRANIOPLUG (October 3, 2014)

FDA data resources